{"abstract":"The Food and Drug Administration (FDA) is classifying the metallic biliary stent system for benign strictures into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the metallic biliary stent system for benign strictures' classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.","action":"Final order.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2016/07/13/2016-16530.html","cfr_references":[{"chapter":null,"citation_url":null,"part":876,"title":21}],"citation":"81 FR 45229","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective July 13, 2016. The classification was applicable on June 3, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-N-1813"],"dockets":[],"document_number":"2016-16530","effective_on":"2016-07-13","end_page":45232,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/07/13/2016-16530.xml","html_url":"https://www.federalregister.gov/documents/2016/07/13/2016-16530/medical-devices-gastroenterology-urology-devices-classification-of-the-metallic-biliary-stent-system","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-16530?publication_date=2016-07-13","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-07-13/2016-16530/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":423,"last_updated":"2026-10-22 16:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-07-13/pdf/2016-16530.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-16530.pdf?1468327647","publication_date":"2016-07-13","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/07/13/2016-16530.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 1- DEN150040 De Novo Request from Boston Scientific Corporation Aug 27 2015 re Medical Devices; Gastroenterology-Urology Devices; Classification of the Metallic Biliary Stent System for Benign Strictures","document_id":"FDA-2016-N-1813-0002"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2016-N-1813","supporting_documents_count":1,"docket_id":"FDA-2016-N-1813","regulation_id_number":null,"title":"Medical Devices; Gastroenterology-Urology Devices; Classification of the Metallic Biliary Stent System for Benign Strictures","checked_regulationsdotgov_at":"2016-08-02T06:00:21Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":45229,"subtype":null,"title":"Medical Devices; Gastroenterology-Urology Devices; Classification of the Metallic Biliary Stent System for Benign Strictures","toc_doc":"Gastroenterology-Urology Devices; Classification of the Metallic Biliary Stent System for Benign Strictures","toc_subject":"Medical Devices:","topics":["Medical devices"],"type":"Rule","volume":81}